Extraction form for project: SGS 2022 Enabling Technologies

Design Details

1. Extracted copublications
Provide citation id (eg, PMID) or other study information for sources of extracted data other than the primary article (eg, protocol article, secondary publications, ClinicalTrials.gov)
2. Study Design
3. Directionality
If unclear or other, explain
4. Study dates
Years that the study was conducted (or that the technologies were used). Just the years. If only a single year, just enter this in Start Year (don't repeat in End Year). If not reported, enter "<" the publication year (eg, if published in 2018, enter "<2018").
Start Year
End Year
5. Funding sources
If industry provided devices etc. for free, count this as industry funding.
6. Study country
If one or more countries is not in list, check "Other" and enter the list (ideally in alphabetical order). If study done in multiple European countries, no need to also check or list the individual countries.
7. Inclusion criteria (specific to GYN surgery)
Describe eligibility criteria related to GYN procedure and vaginal surgical enabling technology use. Enter other eligibility criteria in next section. Be concise. Use well-understood abbreviations. If you copy and paste, please go back and edit/clean up
8. Inclusion criteria, other
As needed, describe other eligibility criteria (not related to GYN procedure or vaginal surgical enabling technology use). Skip if n/a. Be concise. Use well-understood abbreviations. Omit non-salient feature (e.g., informed consent, language). If you copy and paste, please go back and edit/clean up
9. Exclusion criteria
Do not repeat, or be redundant with, inclusion criteria. Be concise. Use well-understood abbreviations. Omit non-salient features. OK to leave this blank if nothing unique to add.
10. Centers (number)
If not explicitly reported, use your best judgment.
11. Surgical teams (number)
If not explicitly reported, use your best judgment.
12. Comments/Notes
13. SECONDARY REVIEWER: Name
Your name (if you are the secondary reviewer)
14. SECONDARY REVIEWER: Corrections to DESIGN DETAILS
List corrections (from your perspective) pertinent to this section/tab. You don't need to list trivial corrections (like typos; except maybe number typos).
15. SECONDARY REVIEWER: Corrections to RESULTS
List corrections (from your perspective) pertinent to the extracted results, including things like comparisons and measures used. You don't need to list trivial corrections (like typos; except maybe number typos).
16. SECONDARY REVIEWER: Complete and checked
For all sections. Secondary reviewer should check the "COMPLETE" box when done. Sunil (or his assignee) will check the FINALIZED box when all set. If there are issues, write a few words to capture them.
2ary review COMPLETE
Extraction FINALIZED

Arms

Arm NameArm Description
Suture capturing deviceVeronikis
ConventionalNo enabling technology

Arm Details

1. Specific technology
Name or other identifier of technology, if not fully described by the Arm Name (not the description of the technology)
Suture capturing device
Conventional
2. Technology description
Description and/or details about technology. Be concise. Omit if nothing additional is necessary.
Suture capturing device
Conventional
3. Other comments/notes
Suture capturing device
Conventional
4. SECONDARY REVIEWER: Corrections to ARMS or ARMS DETAILS
List corrections (from your perspective) pertinent to the extracted arm list or name of arms or arm details. You don't need to list trivial corrections (like typos; except maybe number typos).
Suture capturing device
Conventional

Sample Characteristics

1. No. enrolled
Enrolled or initially included (before dropouts, missing data). Particularly for retrospective studies, may be same as number analyzed. Check NR/unclear if NR.
Suture capturing device
No.
NR
Conventional
No.
NR
Total
No.
NR
2. Surgical indication(s)
For each indication, enter percent (0-100%), not the proportion (0-1). Calculate % from n/N. Confirm that %ages add to 100%. If the %age is NR for given indications, enter NR for those indications. If a listed indication is not included (ie, 0%), leave blank. (Remember that the indications may be listed in the Methods, not the Results). You can skip the Definition column (for specific or all indications). Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
DefinitionPercentage (%)% NR
Bleeding abnormality
Endometriosis
Adenomyosis
Adnexal mass
Cervical dysplasia
Pelvic pain etc.
Prolapse, pelvic organ
Endom Intra Neop (EIN)
BRCA positive
Other 1
Other 2
Other 3
Other 4
Other 5
Difference between groups
Conventional
DefinitionPercentage (%)% NR
Bleeding abnormality
Endometriosis
Adenomyosis
Adnexal mass
Cervical dysplasia
Pelvic pain etc.
Prolapse, pelvic organ
Endom Intra Neop (EIN)
BRCA positive
Other 1
Other 2
Other 3
Other 4
Other 5
Difference between groups
Total
DefinitionPercentage (%)% NR
Bleeding abnormality
Endometriosis
Adenomyosis
Adnexal mass
Cervical dysplasia
Pelvic pain etc.
Prolapse, pelvic organ
Endom Intra Neop (EIN)
BRCA positive
Other 1
Other 2
Other 3
Other 4
Other 5
Difference between groups
3. Surgical procedures
If the procedures are identical in both groups (eg, 100% one procedure) OR if they don't report % within each study group, please ONLY complete the TOTAL section. First click the procedure(s), then enter the percent (0-100%, not proportion [0-1]). If you select either of the "OTHER" options, name these.
Suture capturing device
Conventional
Total
4. Age
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Conventional
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Total
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
5. BMI
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Conventional
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Total
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
6. Race/Ethnicity
Extract or calculate % (0-100%), not proportion (0-1). Skip not relevant or not reported rows. For "Other" categories, Enter description and %. For example: Indian 42%. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
NR
White (all)
White, non-Hispanic
Black/AA (all)
Black/AA, non-Hispanic
Hispanic/Latina
Asian (all)
Other 1
Other 2
Other 3
Other 4
Difference between groups
Conventional
NR
White (all)
White, non-Hispanic
Black/AA (all)
Black/AA, non-Hispanic
Hispanic/Latina
Asian (all)
Other 1
Other 2
Other 3
Other 4
Difference between groups
Total
NR
White (all)
White, non-Hispanic
Black/AA (all)
Black/AA, non-Hispanic
Hispanic/Latina
Asian (all)
Other 1
Other 2
Other 3
Other 4
Difference between groups
7. Parity
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Conventional
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Total
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
8. No. vaginal births
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Conventional
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Total
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
9. No. cesarean sections
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Conventional
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
Total
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
10. Comorbidities
List with %ages or other numerical data, as feasible. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Comorbidities
Differences between groups
Conventional
Comorbidities
Differences between groups
Total
Comorbidities
Differences between groups
11. Prior surgeries
List with %ages or other numerical data, as feasible. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Surgeries
Differences between groups
Conventional
Surgeries
Differences between groups
Total
Surgeries
Differences between groups
12. Uterine size (or weight)
PREOPERATIVE size, including weight. No need to complete more than one row. Select units in the first row. Include ONLY NUMBERS in (one of) the next 3 rows. Check NR if necessary. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Units
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
Conventional
Units
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
Total
Units
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
13. Adnexal mass (or cyst size)
Complete only if adnexal surgery, otherwise, skip. PREOPERATIVE mass. No need to complete more than one row. Select units in the first row. Include ONLY NUMBERS in (one of) the next 3 rows. Check NR if necessary. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Units
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
Conventional
Units
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
Total
Units
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
14. Pelvic/vaginal pain
PREOPERATIVE. Select tool/measure in the first row. If not VAS, name the tool. If CATEGORICAL, define the pain category and in next row(s), enter %age (0-100%). Include ONLY NUMBERS in (one of) the next 3 rows. Check NR if necessary (even if indication does not have a pain component). Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Tool/Measure
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
Conventional
Tool/Measure
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
Total
Tool/Measure
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
15. QoL
PREOPERATIVE. Select questionnaire in the first row; check all tick boxes in first row and answer each: Min-Max: enter range of possible scores; Best QoL = min or max?: enter "min" or "max" to say whether the lowest or highest possible score corresponds to best QoL. Include ONLY NUMBERS in (one of) the next 3 rows. Check NR if necessary. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Questionnaire
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
Conventional
Questionnaire
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
Total
Questionnaire
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
16. Comments/Notes
Suture capturing device
Conventional
Total
17. SECONDARY REVIEWER: Corrections to SAMPLE CHARACTERISTICS
List corrections (from your perspective) pertinent to the extracted sample characteristics. You don't need to list trivial corrections (like typos; except maybe number typos).
Suture capturing device
Conventional
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousSurgery: Procedure/operative time
  • All Participants
  • Intra-op
ContinuousSurgery: EBL
  • All Participants
  • Intra-op
ContinuousResource: Length of hospital stay
  • All Participants
  • Post-op
ContinuousPain: Narcotic useanalgesic (Pethidine HCL) usage (50 mg/ampoule)
  • All Participants
  • Not clear? assume postop but not clear on time frame
ContinuousTime to remove foley catheter#days
  • All Participants
  • PostOp
ContinuousPVRin ML, but not clear when measured
  • All Participants
  • postop-not clear
CategoricalCx: Genitourinary injury
  • All Participants
  • Intraop
CategoricalCx: Bowel injury
  • All Participants
  • Post-op
CategoricalCx: Vascular injury
  • All Participants
  • Post-op

Outcome Details

1. Comments/Notes
Surgery: Procedure/operative time
Surgery: EBL
Resource: Length of hospital stay
Pain: Narcotic use
Time to remove foley catheter
PVR
Cx: Genitourinary injury
Cx: Bowel injury
Cx: Vascular injury
2. SECONDARY REVIEWER: Corrections to OUTCOMES or OUTCOME DETAILS
List corrections (from your perspective) pertinent to the extracted outcome list or name or definition of outcomes, or time points, or outcome details. You don't need to list trivial corrections (like typos; except maybe number typos).
Surgery: Procedure/operative time
Surgery: EBL
Resource: Length of hospital stay
Pain: Narcotic use
Time to remove foley catheter
PVR
Cx: Genitourinary injury
Cx: Bowel injury
Cx: Vascular injury

Risk of Bias Assessment

1. Study Design
Answer this question to allow program to select the right questions for you.
2. Clarity: Discrepancies
Was the article free of discrepancies (eg, between text and tables)? Add note if No (High concern)
3. Clarity: Population
Were patient eligibility criteria sufficiently clear? Add note if No (High concern).
4. Clarity: Intervention (technology) and Comparator
Were the technology and comparator sufficiently clearly described? Add note if No (High concern).
5. Clarity: Outcomes
Were the outcomes adequately defined without problem. Add note if No (High concern). Not every outcome requires an explicit definition (e.g., length of hospital stay).
6. Clarity: Setting
Was the setting sufficiently clearly defined (e.g., the surgical team)? Add note if No (High concern). Not every outcome requires an explicit definition (e.g., length of hospital stay).
7. Random sequence generation
Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence. If they say only "randomized" this says nothing about the random sequence generation (select Unclear and enter "NR"). There is a low risk of selection bias if the investigators describe a random component in the sequence generation process such as: referring to a random number table, using a computer random number generator, coin tossing, shuffling cards or envelopes, throwing dice, drawing of lots, minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random). There is a high risk of selection bias if the investigators describe a non-random component in the sequence generation process, such as: sequence generated by odd or even date of birth, date (or day) of admission, hospital or clinic record number; or allocation by judgement of the clinician, preference of the participant, results of a laboratory test or a series of tests, or availability of the intervention. ADD NOTE IF UNCLEAR (usually "NR") OR HIGH ROB.
Rating
8. Allocation concealment
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment. This usually not reported (select Unclear and enter "NR"). There is a low risk of selection bias if the participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomization); sequentially numbered drug containers of identical appearance; or sequentially numbered, opaque, sealed envelopes. There is a high risk of bias if participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; or other explicitly unconcealed procedures. ADD NOTE IF UNCLEAR (usually enter "NR) OR HIGH ROB.
Rating
9. Blinding of participants and personnel
Performance bias due to knowledge of the allocated interventions by participants during the study. There is a low risk of performance bias if blinding of participants and key study personnel was ensured and it was unlikely that the blinding could have been broken. If unblinded, enter HIGH RoB even if blinding would have been impossible (the RoB still exists). If no mention of blinding use your judgment, erring on the side of unblinded. ADD NOTE ONLY IF there's something atypical beyond lack of blinding.
Rating
10. Blinding of outcome assessor
Detection bias due to knowledge of the allocated interventions by outcome assessors. There is LOW risk of detection bias if the blinding of the outcome assessment was ensured and it was unlikely that the blinding could have been broken. Note that most outcomes of interest could have been assessed by blinded outcome assessors (except, possibly patient-reported or surgeon-reported outcomes; which are addressed by the question about patient/provider blinding). ADD NOTE ONLY IF there's something atypical beyond lack of blinding (of if there was differential blinding for different outcomes). Use your judgment if blinding information was not reported.
Rating
11. Incomplete outcome data
Attrition bias due to amount, nature or handling of incomplete outcome data. There is a LOW risk of attrition bias if there were No missing outcome data; if attrition was <20% and reasons for missing outcome data were unlikely to be related to the true outcome and missing outcome data were BALANCED in % loss, with similar reasons for missing data across groups. ADD NOTE IF UNCLEAR OR HIGH RoB.
Rating
12. Selective Reporting
Reporting bias due to selective outcome reporting. This may be difficult to judge. There is LOW risk of reporting bias if the study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way, or if the study protocol is not available but it is clear that the published reports include all expected outcome, including those that were pre-specified (convincing text of this nature may be uncommon). There is a HIGH risk of reporting bias if not all of the study’s pre-specified primary outcomes have been reported; one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified; one or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study. ADD NOTE IF UNCLEAR OR HIGH RoB.
Rating
13. Intention-to-treat-analysis
Bias due to incomplete reporting and analysis according to group allocation. There is low risk of bias if all randomized patients were reported/analyzed in the group to which they were allocated by randomization. Either with intention-to-treat methods or if there were no dropouts (all analyzed). Note that authors' use of the term ITT does not at all guarantee that ITT methods were used. ADD NOTE ONLY if something unusual.
Rating
14. Representativeness of the cases
LOW RoB if all eligible cases with outcome of interest over a defined period of time OR all cases in a defined catchment area OR all cases in a defined service OR a random sample of those cases; no concern about biased selection of patients. ADD NOTE IF UNCLEAR OR HIGH RoB.
Rating
15. Selection of Controls
LOW RoB if Controls were selected from the same source population as the cases AND essentially the same eligibility criteria (except for intervention). HIGH RoB if Controls were selected from a different source population that was not completely comparable OR different basic eligibility criteria. ADD NOTE IF UNCLEAR OR HIGH ROB.
Rating
16. Other Bias
Bias due to problems not covered elsewhere in the table. If yes (High RoB), describe them in the Notes.There is a LOW risk of bias if the study appears to be free of other sources of bias not addressed elsewhere
Rating

Results

Categorical


Cx: Genitourinary injury

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
Intraop
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional

Cx: Bowel injury

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
Post-op
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional

Cx: Vascular injury

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
Post-op
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional

Continuous


Surgery: Procedure/operative time

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
Intra-op
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
Minimum
95% CI high (MD)
Maximum
SD (MD)
Note
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional

Surgery: EBL

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
Intra-op
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
Minimum
95% CI high (MD)
Maximum
SD (MD)
Note
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional

Resource: Length of hospital stay

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
Post-op
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
Minimum
95% CI high (MD)
Maximum
SD (MD)
Note
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional

Pain: Narcotic use (analgesic (Pethidine HCL) usage (50 mg/ampoule))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
Not clear? assume postop but not clear on time frame
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
Minimum
95% CI high (MD)
Maximum
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional

Time to remove foley catheter (#days)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
PostOp
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
Minimum
95% CI high (MD)
Maximum
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional

PVR (in ML, but not clear when measured)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing deviceConventional
postop-not clear
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
Minimum
95% CI high (MD)
Maximum
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing deviceConventional