NCT01288599

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 3, 2012

Status Verified

February 1, 2011

Enrollment Period

8 months

First QC Date

November 18, 2010

Last Update Submit

June 29, 2012

Conditions

Ovarian Cyst

Keywords

LaparoscopyRandomizedSingle port accessAdnexal diseaseLESS

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Experienced pain over the last six hours measured on a VAS scale.

    6 hours

Secondary Outcomes (6)

  • Satisfaction with cosmetic result

    2 months postoperatively

  • Operation time

    0 hours after the operation

  • Blood loss

    0 hours after the operation

  • Complications

    Two months

  • Shoulder tip pain

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

Single port access laparoscopy

EXPERIMENTAL

Single port access laparoscopy for benign adnexal disease.

Procedure: Laparoscopic surgery

Conventional laparoscopy

ACTIVE COMPARATOR

Conventional laparoscopy for benign adnexal disease.

Procedure: Laparoscopic surgery

Interventions

Laparoscopic surgeryPROCEDURE

Laparoscopic surgery where adnexectomy or cystectomy is performed.

Conventional laparoscopySingle port access laparoscopy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SorlandetHF Hospital

Kristiansand, 4604, Norway

Location

Related Publications (1)

  • Hoyer-Sorensen C, Vistad I, Ballard K. Is single-port laparoscopy for benign adnexal disease less painful than conventional laparoscopy? A single-center randomized controlled trial. Fertil Steril. 2012 Oct;98(4):973-9. doi: 10.1016/j.fertnstert.2012.06.016. Epub 2012 Jul 4.

    PMID: 22769732DERIVED

MeSH Terms

Conditions

Ovarian CystsAdnexal Diseases

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2010

First Posted

February 2, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

July 3, 2012

Record last verified: 2011-02

Locations

NO(1)