A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer

NCT01886508 | Unknown DMC

• 1 other identifier: NCT00270426
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (5)

• maximum flow rate measured by Urodynamic at 6 months postoperative

  on 6 months postoperative

• residual volume measured by Urodynamic at 6 months postoperative

  on 6 months postoperative

• maximum vesical compliace measured by Urodynamic at 6 months postoperative

  on 6 months postoperative

• cystometric capacity at first desire measured by Urodynamic at 6 months postoperative

  on 6 months postoperative

• maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative

  on 6 months postoperative

Secondary Outcomes (9)

• Time (days) to residual urine volume less than 100ml postoperative

  from operation to residual urine volume less than 100ml, assessed up to 30 days

• time (hours) to break wind postoperative

  from operation to have the first break wind, assessed up to 72 hours

• time (hours) to defecation postoperative

  from operation to have the first defection, assessed up to 72 hours

• Number of participants with adverse events

  From date of operation until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 5 years

• Score of MHU rating scales at 6 months postoperative

  on 6 months postoperative

Study Arms (2)

NSRH

EXPERIMENTAL

patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)

Procedure: Nerve-spring radical hysterectomy

RH

ACTIVE COMPARATOR

patients in Arm RH undergo radical hysterectomy (RH)

Procedure: radical hysterectomy

Interventions

Nerve-spring radical hysterectomy PROCEDURE

Nerve-spring radical hysterectomy that is reserve some pelvic autonomic nerves during radical hysterectomy. Reserve hypogastric nerve trunk during dissecting cardinal ligament. Reserve pelvic splanchnic nerve trunk during exsecting uterosacral ligament. Reserve bladder nerve of pelvic plexus during dissecting vesicouterine ligament.

NSRH

radical hysterectomy PROCEDURE

Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.

RH

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• FIGO(2009) stage Ia2, Ib1, and IIa1 Untreated cervical cancer OR FIGO(2009) stage Ib2 and IIa2 cervical cancer that possible to surgery after neoadjuvant chemotherapy
• Possible to radical hysterectomy or nerve-spring radical hysterectomy
• Age: 17 to 60 years
• No complication during operation
• Written informed consent

You may not qualify if:

• patients who underwent radiotherapy
• Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma
• Patients who have uncontrolled diabetes or uncontrolled hypertension
• patients with neurogenic bladder dysfunction
• patients with uterine prolapse
• Patients with psychiatric illness
• Patients who have active infection
• Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months
• Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Tumor Hospital of Xin Jiang Medical University,China: collaborator
• Gui Yang Maternal and Child Health Hospital,China: collaborator
• The 152nd Hospital of chinese People's Liberation Army: collaborator

Study Sites (1)

Southern Medical University, China

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Chenlin Chen, M.D.,Ph.D.

CONTACT

+8602062787947; chenchunlinrct@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: June 26, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: July 22, 2013

Record last verified: 2013-05

Locations

CN (1)