NCT07109193

Brief Summary

To assess the effect of intraperitoneal drain placement on postoperative pain after Gynecologic laparoscopy To evaluate whether the use of drains contributes to improved other clinical outcomes

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2025

Typical duration for all trials

Status
not yet recruiting

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

Study Progress33%
Sep 2025Oct 2027

First Submitted

Initial submission to the registry

June 26, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

June 26, 2025

Last Update Submit

July 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Corelation between intraperitoneal drain placement and Postoperative pain in Gynecologic laparoscopy

    Evalute post operative pain levels and discomfort through Visual Analouge Scale (VAS) score

    Baseline

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of women undergoing elective laparoscopic gynecologic surgery at \[Insert Hospital/Institution Name\] over a \[insert duration, e.g., 6-month or 12-month\] period. Eligible participants will be adult females aged 18 to 65 years who are scheduled for non-oncologic, minimally invasive gynecologic procedures such as ovarian cystectomy, salpingectomy, diagnostic laparoscopy, or laparoscopic management of endometriosis.

You may qualify if:

  • Elective procedure: Patients scheduled for elective pure laparoscopic gynecologic surgery (e.g., ovarian cystectomy, endometriosis resection, diagnostic laparoscopy).
  • ASA Physical Status: I-II (i.e., healthy or mild systemic disease).
  • BMI: 18-35 kg/m².
  • Informed Consent: Able and willing to give written consent and comply with postoperative pain assessments.

You may not qualify if:

  • Malignancy: Known or suspected gynecologic malignancy requiring staging or radical surgery.
  • \. Conversion: Intraoperative conversion to laparotomy.
  • \. Coagulopathy: Bleeding disorders or therapeutic anticoagulation that cannot be paused perioperatively.
  • \. Prior Major Pelvic Surgery: ≥ 2 previous open abdominal operations (to avoid confounding from adhesions).
  • \. Intra-Abdominal Infection: Active pelvic inflammatory disease or untreated urinary tract infection.
  • \. Chronic Pain/Opioid Use: Regular opioid use or chronic pelvic pain syndromes (endometriosis pain \> 6 months).
  • \. Allergy/Contraindication: Allergy to standard analgesics or contraindication to intraperitoneal drain placement (e.g., severe adhesions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kerimoglu OS, Yilmaz SA, Pekin A, Incesu F, Dogan NU, Ilhan TT, Celik C. Effect of drainage on postoperative pain after laparoscopic ovarian cystectomy. J Obstet Gynaecol. 2015 Apr;35(3):287-9. doi: 10.3109/01443615.2014.948824. Epub 2014 Aug 20.

    PMID: 25140836BACKGROUND
  • Abbott J, Hawe J, Srivastava P, Hunter D, Garry R. Intraperitoneal gas drain to reduce pain after laparoscopy: randomized masked trial. Obstet Gynecol. 2001 Jul;98(1):97-100. doi: 10.1016/s0029-7844(01)01383-7.

    PMID: 11430964BACKGROUND
  • Swift G, Healey M, Varol N, Maher P, Hill D. A prospective randomised double-blind placebo controlled trial to assess whether gas drains reduce shoulder pain following gynaecological laparoscopy. Aust N Z J Obstet Gynaecol. 2002 Aug;42(3):267-70. doi: 10.1111/j.0004-8666.2002.00267.x.

    PMID: 12230061BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 26, 2025

First Posted

August 7, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share