Hysterectomy for Benign Gynaecological Conditions With or Without Tubectomy

NCT02281487 | Completed

• 2 other identifiers: HYSTUBNL39317.028.12
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine whether a tubectomy during hysterectomy for benign gynaecological conditions does not result into a premature menopause.

Conditions

Abdominal Hysterectomy (& Wertheim)

Keywords

tubal carcinoma; ovarian carcinoma; tubectomy; hysterectomy; dysplastic changes; Anti Mullerian Hormone; Tubal Intraepithelial Carcinoma; Salpingectomy

Outcome Measures

Primary Outcomes (1)

• Anti Mullerian Hormone

  Difference, if any, in concentration of Anti Mullerian Hormone one day prior to hysterectomy and on average around six months after surgery between the study groups (hysterectomy alone versus hysterectomy and tubectomy).

  at baseline and on average six months after the operation

Secondary Outcomes (1)

• Dysplasia

  on average six months after the operation

Study Arms (2)

Hysterectomy

ACTIVE COMPARATOR

standard hysterectomy

Procedure: Hysterectomy

Hysterectomy plus tubectomy

EXPERIMENTAL

Hysterectomy plus tubectomy

Procedure: Hysterectomy plus Tubectomy; Device: light microscopy

Interventions

Hysterectomy plus Tubectomy PROCEDURE

hysterectomy with tubectomy

Hysterectomy plus tubectomy

Hysterectomy PROCEDURE

standard hysterectomy

Hysterectomy

light microscopy DEVICE

analysis of the incidence of dysplastic lesions (defined as: nuclear atypia, pilling of epithelial cells, multiple mitosis), if any, in the removed Fallopian tubes by light microscopy (Leica DM4000)

Hysterectomy plus tubectomy

Eligibility Criteria

• Age: 36 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• hysterectomy (abdominally or laparoscopically) for benign indications
• premenopausal
• age \>36 \< 55

You may not qualify if:

• history of cancer
• hereditary cancer in the family
• previous intraluminal tubal occlusion
• previous salpingitis
• failure to perform a tubectomy during hysterectomy

Sponsors & Collaborators

• Gynaecologisch Oncologisch Centrum Zuid: lead
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Radboud University Medical Center: collaborator
• Jeroen Bosch Ziekenhuis: collaborator

Study Sites (5)

Radboudumc

Nijmegen, Gelderland, Netherlands

Location

Jeroen Bosch ziekenhuis

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Elisabeth ziekenhuis

Tilburg, North Brabant, 5022 GC, Netherlands

Location

TweeStedenziekenhuis

Tilburg, North Brabant, 5042AD, Netherlands

Location

Related Publications (5)

• Piek JM, van Diest PJ, Zweemer RP, Kenemans P, Verheijen RH. Tubal ligation and risk of ovarian cancer. Lancet. 2001 Sep 8;358(9284):844. doi: 10.1016/S0140-6736(01)05992-X. No abstract available.

  PMID: 11570411 BACKGROUND

• Kurman RJ, Shih IeM. The origin and pathogenesis of epithelial ovarian cancer: a proposed unifying theory. Am J Surg Pathol. 2010 Mar;34(3):433-43. doi: 10.1097/PAS.0b013e3181cf3d79.

  PMID: 20154587 BACKGROUND

• Crum CP. Intercepting pelvic cancer in the distal fallopian tube: theories and realities. Mol Oncol. 2009 Apr;3(2):165-70. doi: 10.1016/j.molonc.2009.01.004. Epub 2009 Feb 3.

  PMID: 19383378 BACKGROUND

• Sezik M, Ozkaya O, Demir F, Sezik HT, Kaya H. Total salpingectomy during abdominal hysterectomy: effects on ovarian reserve and ovarian stromal blood flow. J Obstet Gynaecol Res. 2007 Dec;33(6):863-9. doi: 10.1111/j.1447-0756.2007.00669.x.

  PMID: 18001455 BACKGROUND

• Narod SA, Sun P, Ghadirian P, Lynch H, Isaacs C, Garber J, Weber B, Karlan B, Fishman D, Rosen B, Tung N, Neuhausen SL. Tubal ligation and risk of ovarian cancer in carriers of BRCA1 or BRCA2 mutations: a case-control study. Lancet. 2001 May 12;357(9267):1467-70. doi: 10.1016/s0140-6736(00)04642-0.

  PMID: 11377596 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Hysterectomy; Salpingectomy; Microscopy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jurgen M Piek, MD. PhD.

  Gynaecologisch Oncologisch Centrum Zuid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: November 3, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

NL (5)