Text Size

Single Versus Conventional Laparoscopy for Benign Adnexal Disease

This study has been completed.
Sponsor:
Collaborator:
University of Surrey
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01288599
First received: November 18, 2010
Last updated: June 29, 2012
Last verified: February 2011
History of Changes
  Purpose

Keyhole surgery for adnexal disease has traditionally been performed using three or four small incisions. The last years a new operating method has been introduced. This method makes use of only one incision of 2 cm in the umbilicus. This method is less invasive, and it might benefit the patient through less postoperative pain and a higher satisfaction with the cosmetic result. So far, many studies have shown that this new method is feasible for adnexal disease, but its superiority compared to conventional laparoscopy is to be proven. This study aims to show this difference.

The investigators aim to compare experienced postoperative pain and use of analgesics in patients undergoing single port laparoscopy for benign adnexal disease with conventional laparoscopy. The investigators hypothesize that the patients will experience less postoperative pain and use less analgesic in the single port laparoscopy group.

Further, the investigators aim to compare the satisfaction with the cosmetic results in the two groups. In addition, blood loss, operating time, complications and conversion to conventional laparoscopy will be registered in the two groups.


Condition Intervention Phase
Ovarian Cyst
 Procedure: Laparoscopic surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Single Port Laparoscopy Versus Conventional Laparoscopy for Benign Adnexal Disease - A Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Experienced pain over the last six hours measured on a VAS scale.


Secondary Outcome Measures:
  • Satisfaction with cosmetic result [ Time Frame: 2 months postoperatively ] [ Designated as safety issue: No ]
    Satisfaction with cosmetic result, self reported and based on the Manchester scar scale.

  • Operation time [ Time Frame: 0 hours after the operation ] [ Designated as safety issue: No ]
    Operating time in minutes.

  • Blood loss [ Time Frame: 0 hours after the operation ] [ Designated as safety issue: No ]
    Estimated blood loss in ml.

  • Complications [ Time Frame: Two months ] [ Designated as safety issue: No ]
    Complications during surgery and late complications.

  • Shoulder tip pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Experienced shoulder tip pain over the last 24 hours measured on a VAS scale.

  • Postoperative pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Experienced pain over the last 24 hours measured on a VAS scale.


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single port access laparoscopy
Single port access laparoscopy for benign adnexal disease.
 Procedure: Laparoscopic surgery
Laparoscopic surgery where adnexectomy or cystectomy is performed.
Active Comparator: Conventional laparoscopy
Conventional laparoscopy for benign adnexal disease.
 Procedure: Laparoscopic surgery
Laparoscopic surgery where adnexectomy or cystectomy is performed.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ≥ 18 years.
  • ASA score 1 or 2.
  • Presumed benign ovarian disease or a hereditary cancer risk.
  • Ovarian cyst ≤ 6 cm.

Exclusion Criteria:

  • Ovarian cyst > 6 cm.
  • Endometrioma.
  • Endometriosis.
  • History of chronic pelvic pain.
  • Known severe intra abdominal adhesions.
  • Daily use of analgesics.
  • Inability to understand Norwegian or English.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288599

Locations
Norway
SorlandetHF Hospital
Kristiansand, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
University of Surrey
  More Information

No publications provided by Sorlandet Hospital HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01288599     History of Changes
Other Study ID Numbers: Laparoscopy SSK
Study First Received: November 18, 2010
Last Updated: June 29, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Sorlandet Hospital HF:
Laparoscopy
Randomized
Single port access
Adnexal disease
LESS

Additional relevant MeSH terms:
Adnexal Diseases
Ovarian Cysts
Genital Diseases, Female
Cysts
 Neoplasms
Ovarian Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013