NCT03254056

Brief Summary

This study compares post-operative incisional pain on post-operative days 1 and 7 who will undergo gynecologic laparoscopic operations. Half of participants will undergo conventional fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl Storz, Belgium).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

August 14, 2017

Last Update Submit

June 25, 2018

Conditions

Post-operative PainFascial Closure

Keywords

fascial closure devicelaparoscopic surgerypostoperative pain

Outcome Measures

Primary Outcomes (2)

  • Post-operative incisional pain

    Visual Analog Scale

    24 hours after fascial closure closure

  • Post-operative incisional pain

    Visual Analog Scale

    7 days after fascial closure closure

Secondary Outcomes (1)

  • Time for fascial closure

    Intraoperative

Study Arms (2)

Conventional Technique

ACTIVE COMPARATOR

The edges of the fascia will be hold by the surgical instruments. The fascial defect will be repaired by using devices which are generated for laparotomy operations.

Procedure: Conventional technique

Berci Technique

ACTIVE COMPARATOR

This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.

Procedure: Berci technique

Interventions

Conventional techniquePROCEDURE

Conventional technique: In this group; S-retractors will be used to visualize the fascia and a single interrupted stitch will be placed using 0-vicryl suture.

Conventional Technique
Berci techniquePROCEDURE

Berci group: In this group; the fascial incision will be closed with the fascial closure device, (Berci Fascial Closure instrument) using 1 interrupted stitch with 0-vicryl suture.

Berci Technique

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-65 years
  • Ability to understand the inform consent
  • No conversion from laparoscopy to laparotomy

You may not qualify if:

  • No-ability to understand the inform consent
  • Conversion to laparotomy from laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Women Health Education and Research Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

  • Lyapis A, Ulrich A, LaMonica R, Kuo CL, Kaye L, Luciano D. Does the Difference in Fascial Closure Technique Affect Postoperative Pain? J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1190-1194. doi: 10.1016/j.jmig.2017.07.020. Epub 2017 Jul 27.

    PMID: 28757438RESULT

  • Williams CP, Rosen MJ, Jin J, McGee MF, Schomisch SJ, Ponsky J. Objective analysis of the accuracy and efficacy of a novel fascial closure device. Surg Innov. 2008 Dec;15(4):307-11. doi: 10.1177/1553350608327168.

    PMID: 19036733RESULT

  • Elashry OM, Nakada SY, Wolf JS Jr, Figenshau RS, McDougall EM, Clayman RV. Comparative clinical study of port-closure techniques following laparoscopic surgery. J Am Coll Surg. 1996 Oct;183(4):335-44.

    PMID: 8843262RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Yaprak Üstün, Prof

    University of Health Sciences, Zekai Tahir Burak Women's Health Health Research and Practice Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 18, 2017

Study Start

October 3, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)