Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

NCT01344486 | Terminated Phase 4

• 1 other identifier: S52424
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease post-operative pain, inflammation and adhesion formation. Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain and adhesion formation.

Conditions

Endometriosis of the Cul-de-sac; Chocolate Cyst of Ovary; Fibroid/Myoma (Uterus/Cervix)

Keywords

women undergoing laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• adhesion formation after laparoscopic surgery

  second look laparoscopy to assess adhesions formed after initial surgery

  2 weeks after primary surgery

Secondary Outcomes (3)

• Post-operative pain

  recorded until 3 days after surgery

• inflammation

  recorded until 3 days after surgery

• time to first flatus and stool

  recorded until 3 days after surgery

Study Arms (2)

Full conditioing

EXPERIMENTAL

Intervention by alteration of laparoscopic gas with addition of oxygen and nitrous oxide, regulation of humidification and temperature (32°C), injection of 5mg Dexamethasone and application of Hyalobarrier Gel Endo (Nordic Pharma) at the surgical wound

Procedure: full conditioning

carbon dioxide

ACTIVE COMPARATOR

induction pneumoperitoneum with carbon dioxide 100%

Procedure: standard pneumoperitoneum

Interventions

full conditioning PROCEDURE

addition of 4% oxygen + 10% nitrous oxide to the pneumoperitoneum + humidification + temperature regulation at 32°C

Full conditioing

standard pneumoperitoneum PROCEDURE

100% carbon dioxide used for the pneumoperitoenum

carbon dioxide

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women undergoing laparoscopic excision of deep endometriosis (stratum 1), excision of endometrioma's (stratum 2) or excision of uterine myoma's (stratum 3) since this is severe surgery, associated with severe postoperative adhesions and since for most of these women fertility is important and hence the second look laparoscopy can be beneficial.
• Signed informed consent

You may not qualify if:

• women with a pre-existing condition increasing the risk of surgery such as clotting disorders, heart or lung impairment etc.-Any condition that might interfere with inflammatory parameters such as immunodeficiency, chronic inflammatory disease as Crohn's disease.
• Pregnancy
• Conditions associated with chronic pain as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease. Conditions causing acute pain e.g. abdominal trauma
• a known allergic reaction to Hyalobarrier Gel Endo®
• A bowel lesion requiring a single or double layer suture. (given that for none of the anti-adhesion barriers safety has been proven following bowel lesions and suture)

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Endometriosis; Leiomyoma; Myoma

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Philippe Koninckx, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 29, 2011
• Study Start: September 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)