The Relationship Between Intraperitoneal Drain Placement and Postoperative Pain in Gynecologic Laparoscopy
1 other identifier
observational
76
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2025
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2025
CompletedFirst Posted
Study publicly available on registry
August 7, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
August 7, 2025
July 1, 2025
2 years
June 26, 2025
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
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: 25140836BACKGROUNDAbbott 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: 11430964BACKGROUNDSwift 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