Urinary and Sexual Functions After Subtotal Versus Total Abdominal Hysterectomy

NCT03087565 | Unknown DMC

• 1 other identifier: 162
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

All hysterectomies were performed intrafascially using the clamp-cut-ligate method as described by (Jones, 2003); Careful examination under anesthesia. Catheterization by N. 18 Foley's catheter and its balloon Filled with 10-ml saline.A transverse lower abdominal incision (Pfannenstiel incision) ranging from 8-12 cm through which the abdomen is opened in layers. During subtotal hysterectomy procedure, the corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures. During total hysterectomy procedure, the urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done using a finger pushed gently against the cervix rather than against the bladder. Sharp dissection using Metzenbaum scissors is performed in patients with previous cesarean sections, with upward traction on the bladder peritoneum and the uterine fundus stretched tightly out of the pelvis, the tips of the Metzenbaum scissors rest lightly on the fascia overlying the cervix with small bites to develop a tissue plane, dissecting the bladder from the anterior cervix. Revision of all pedicles to ensure hemostasis. Intraoperative antibiotics (1 gm of a 3rd generation cephalosporin + 0.5 gm metronidazole). The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination in the pathology Unit.

Conditions

Sexual Function Disturbances; Urinary Function Disorders

Outcome Measures

Primary Outcomes (2)

• Filling cystometry

  The patient presented with a symptomatically full bladder. She voided spontaneously in a uroflow chair. Maximum flow rate and postvoid residual urine volume were obtained via a transurethral catheter. The microtransducer catheters were connected to the appropriate cables and to the tubing from the water pump. With the patient in the supine position on a urodynamic chair, the abdominal catheter was placed into the vagina. A dual microtransducer 6-French catheter with a filling port was then placed into the bladder. The patient was moved to a sitting position. After the catheters were appropriately placed, the subtraction was checked by asking the patient to cough. Cough-induced pressure spikes should be seen on the Pves and Pabd channels, but not on the true detrusor pressure channel.

  6 months after operation

• Uroflowmetry

  The urinary bladder was filled with normal saline at room temperature with a filling rate 50-100 ml/min. First desire to void and strong desire to void were recorded. Throughout the filling portion of the examination, the patient was asked to perform provocative activities, such as coughing and straining. The external urethral meatus was constantly observed for any involuntary urine loss.

  6 months after operation

Secondary Outcomes (1)

• Sexual functions

  6 months after operation

Study Arms (2)

subtotal hystrectomy

ACTIVE COMPARATOR

Careful examination under anesthesia. Catheterization by N. 18 Foley's catheter . A transverse lower abdominal incision (Pfannenstiel incision) . the corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures. Intraoperative antibiotics The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination .

Procedure: subtotal hystrectomy

Total hyterectomy

ACTIVE COMPARATOR

examination under anesthesia. Catheterization by N. 18 Foley's catheter A transverse lower abdominal incision (Pfannenstiel incision) The urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done . Sharp dissection using Metzenbaum scissors is performed in patients with previous cesarean sections Revision of all pedicles to ensure hemostasis. Intraoperative antibiotics The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination .

Procedure: Total hystrectomy

Interventions

subtotal hystrectomy PROCEDURE

A transverse lower abdominal incision (Pfannenstiel incision) The corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures. Revision of all pedicles to ensure hemostasis. Intraoperative antibiotics . The abdomen is closed in layers; the wound is covered with a sterile dressing.

subtotal hystrectomy

Total hystrectomy PROCEDURE

A transverse lower abdominal incision (Pfannenstiel incision) The urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Revision of all pedicles to ensure hemostasis. The abdomen is closed in layers; the wound is covered with a sterile dressing.

Total hyterectomy

Eligibility Criteria

• Age: 35 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• An age over 35 and below 50 years.
• Menstruating women.
• No symptomatic uterine prolapse. .
• Normal cervical smears.
• Benign lesions.
• Active sexual life.
• Functioning ovaries.

You may not qualify if:

• Known endometriosis.
• Overt neurological or psychiatric disorder.
• Candidate for vaginal hysterectomy.
• Use of hormone replacement therapy.
• Oophorectomy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

01005227404; prof.ahmedmaged@gmail.com

Ashraf Eldaly, MD

CONTACT

eldalyashraf@gmail.com

Study Design

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

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: March 22, 2017
• Study Start: April 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)