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Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

Primary Purpose

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

Status

Terminated

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

full conditioning

standard pneumoperitoneum

About this trial

This is an interventional prevention trial for Endometriosis of the Cul-de-sac focused on measuring women undergoing laparoscopic surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full conditioing

carbon dioxide

Arm Description

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

induction pneumoperitoneum with carbon dioxide 100%

Outcomes

Primary Outcome Measures

adhesion formation after laparoscopic surgery

second look laparoscopy to assess adhesions formed after initial surgery

Secondary Outcome Measures

Post-operative pain

pain assessed by VAS scores

inflammation

bloodsamples to test for C reactive protein and white blood cells

time to first flatus and stool

patients will be asked when first flatus and first stool appeared. (measured as hours after surgery)

Full Information

NCT ID

NCT01344486

First Posted

April 21, 2011

Last Updated

October 24, 2016

Sponsor

University Hospital, Gasthuisberg

1. Study Identification

Unique Protocol Identification Number

NCT01344486

Brief Title

Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

Official Title

Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Why Stopped

Investigator no longer works fulltime at investigational site

Study Start Date

September 2010 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Gasthuisberg

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Randomized controlled trial (RCT) comparing carbon dioxide to full conditioning (addition of oxygen, nitrous oxide, humidification and temperature control, dexamethasone and Hyalobarrier gel) Women undergoing laparoscopy for endometriosis, myomectomy or adhesiolysis will be randomized to either group and will be compared for pain (VAS scores); inflammation (White blood cells, CRP) and adhesions scored by second look laparoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

women undergoing laparoscopic surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Full conditioing

Arm Type

Experimental

Arm Description

Arm Title

carbon dioxide

Arm Type

Active Comparator

Arm Description

induction pneumoperitoneum with carbon dioxide 100%

Intervention Type

Procedure

Intervention Name(s)

full conditioning

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

standard pneumoperitoneum

Intervention Description

100% carbon dioxide used for the pneumoperitoenum

Primary Outcome Measure Information:

Title

adhesion formation after laparoscopic surgery

Description

second look laparoscopy to assess adhesions formed after initial surgery

Time Frame

2 weeks after primary surgery

Secondary Outcome Measure Information:

Title

Post-operative pain

Description

pain assessed by VAS scores

Time Frame

recorded until 3 days after surgery

Title

inflammation

Description

bloodsamples to test for C reactive protein and white blood cells

Time Frame

recorded until 3 days after surgery

Title

time to first flatus and stool

Description

patients will be asked when first flatus and first stool appeared. (measured as hours after surgery)

Time Frame

recorded until 3 days after surgery

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Koninckx, MD, PhD

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

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Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

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