The Relationship Between Intraperitoneal Drain Placement and Postoperative Pain in Gynecologic Laparoscopy

NCT ID: NCT07109193

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-10-01

Brief Summary

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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

Detailed Description

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Operative laparoscopy is becoming the primary approach for treatment of benign gynaecologic diseases, as it is a less invasive procedure and can help shorten the length of hospitalization., Most complications occur during abdominal access or port placement, while other complications arise during abdominal insufflations, tissue dissection, and homeostasis. However, postoperative pain at the shoulder and upper abdomen has been shown to be the most common complaint in many studies. It has been hypothesized that this is due to CO2 residue, which causes stretching of the post distended diaphragm and peritoneum after prolonged surgery. The suprapubic pain comes directly from the surgical wound, which is also affected by postoperative abdominal distension Several methods have been recommended to improve postoperative pain for ambulatory procedures, including a pulmonary recruitment maneuver,intraperitoneal infusions with saline or analgesic drugs,low pressure laparoscopic surgery,and the prescription of different types of preoperative medicine.Studies have shown peritoneal gas drain to be a procedure that could potentially be used to alleviate postoperative pain. Many previous studies have reported good results from using this procedure. Recently, a systematic review mentioned that there was little evidence to support the effectiveness of intraperitoneal gas drain in reducing postoperative pain.

Conditions

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Hysterectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

1 - Malignancy: Known or suspected gynecologic malignancy requiring staging or radical surgery.

2\. Conversion: Intraoperative conversion to laparotomy.

3\. Coagulopathy: Bleeding disorders or therapeutic anticoagulation that cannot be paused perioperatively.

4\. Prior Major Pelvic Surgery: ≥ 2 previous open abdominal operations (to avoid confounding from adhesions).

5\. Intra-Abdominal Infection: Active pelvic inflammatory disease or untreated urinary tract infection.

6\. Chronic Pain/Opioid Use: Regular opioid use or chronic pelvic pain syndromes (endometriosis pain \> 6 months).

7\. Allergy/Contraindication: Allergy to standard analgesics or contraindication to intraperitoneal drain placement (e.g., severe adhesions).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud qayed mohamed abed

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mahmoud Qayed

Role: CONTACT

0201142914797

References

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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.

Reference Type BACKGROUND
PMID: 25140836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11430964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12230061 (View on PubMed)

Other Identifiers

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Intraperitoneal drain

Identifier Type: -

Identifier Source: org_study_id

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