NCT01289314

Brief Summary

Objective: To compare the occurrence and intensity of pelvic pain as well as patient satisfaction and quality of life after total laparoscopic and laparoscopic supracervical hysterectomy. Design: Prospective randomised trial. Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic pain following TLH compared with following LSH. Null hypothesis 2: There is no significant difference in patient satisfaction and quality of life following TLH compared with following LSH.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 10, 2011

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

February 2, 2011

Last Update Submit

February 9, 2011

Conditions

Total Laparoscopic HysterectomyLaparoscopic Supracervical HysterectomyFibromasAbnormal Uterine BleedingDysmenorrhea

Keywords

total laparoscopic hysterectomylaparoscopic supracervical hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure.

    10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%).

    12 months after the procedure

Secondary Outcomes (8)

  • Patient satisfaction after the procedure

    12 months after the procedure

  • Occurrence of vaginal bleeding after the procedure

    12 months after the procedure

  • Improvement in patient Quality of Life after the procedure

    12 months after the procedure

  • Frequency of perioperative and postoperative complications.

    Perioperative and the periode 12 months after the prosedure

  • Frequency of menopause

    12 months after surgery

  • +3 more secondary outcomes

Study Arms (2)

Total laparoscopic hysterectomy

ACTIVE COMPARATOR
Procedure: TLH

Laparoscopic supracervical hysterectomy

ACTIVE COMPARATOR
Procedure: Laparoscopic supracervical hysterectomy

Interventions

TLHPROCEDURE

Total laparoscopic hysterectomy (TLH)

Total laparoscopic hysterectomy
Laparoscopic supracervical hysterectomyPROCEDURE

Laparoscopic supracervical hysterectomy (LSH)

Laparoscopic supracervical hysterectomy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Premenopausal women who are referred to the department
  • benign condition requiring hysterectomy
  • Dysmenorrohea/cyclic pelvic pain
  • Informed consent

You may not qualify if:

  • Women who are unable to communicate in Norwegian language.
  • Women with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative cervical smear.
  • Women with atypical hyperplasia or malignancy in preoperative endometrial biopsy.
  • Women with a substantially enlarged uterus requiring abdominal hysterectomy or not suitable for TLH (\> 12 week amenorrhea).
  • Women with a concomitant condition requiring uni- or bilateral oophorectomy.
  • Postmenopausal women.
  • Women with no dysmenorrohea/cyclic pelvic pain (\<1 on a 10-point visual analogue scale).
  • Women with deep infiltrating endometriosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Gynecology, Oslo University Hospital

Oslo, Oslo County, Norway

RECRUITING

Related Links

MeSH Terms

Conditions

FibromaMetrorrhagiaDysmenorrhea

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Marit Lieng, MD PHD

    Dept. of Gynecology, Oslo University Hospital, Norway

    STUDY DIRECTOR

Central Study Contacts

Espen Berner, MD

CONTACT

0047 22119800espen.berner@uus.no

Marit Lieng, MD, PHD

CONTACT

0047 22119800marit.lieng@uus.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2011

First Posted

February 3, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

February 10, 2011

Record last verified: 2011-02

Locations

NO(1)