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Laparoscopic Versus Transvaginal Cuff Closure

Primary Purpose

Vaginal Cuff Dehiscence, Vaginal Hematoma, Vaginal Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopical l cuff closure
Sponsored by
El-Galaa Military Medical Complex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Cuff Dehiscence

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients candidate for total laparoscopic hysterectomy :

    • Uterine size <12 weeks.
    • Having no severe endometriosis.
    • Having descent of no more than 1st degree of uterus.
    • Non-malignant conditions.
  2. Completion of the entire procedure by laparoscopic approach up to colpotomy.
  3. Benign conditions as indications for hysterectomy.

Exclusion Criteria:

- 1) Obese patients i.e., BMI > 30 k.g\m2. 2) Suspected extensive pelvic adhesions . 3) Factors which may prolong wound healing as uncontrolled diabetes, ,prolonged corticosteroid therapy ,advanced liver diseases.

4) Inability to express adequate informed consent to participate in the study.

Sites / Locations

  • Ain Shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laparoscopical l cuff closure

transvaginal cuff closure

Arm Description

needle holder laparoscopic vaginal cuff closure

transvaginal cuff closure

Outcomes

Primary Outcome Measures

1. number of cases ofVaginal cuff dehiscence
Any separation at the level of the vaginal vault.

Secondary Outcome Measures

number of cases with vaginal hematoma
ultrasound finding
number of cases with vaginal infection
purulent vaginal discharge

Full Information

First Posted
March 21, 2019
Last Updated
December 10, 2021
Sponsor
El-Galaa Military Medical Complex
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1. Study Identification

Unique Protocol Identification Number
NCT03898726
Brief Title
Laparoscopic Versus Transvaginal Cuff Closure
Official Title
Comparison Between Laparoscopic Versus Transvaginal Cuff Closure After Total Laparoscopic Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
May 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
El-Galaa Military Medical Complex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
It is still debatable whether that the transvaginal approach to vault closure or laparoscopic suturing are associated with lower risks of vaginal cuff complications . This study aims to compare the two approaches of closure of the vaginal cuff at the end of total laparoscopic hysterectomy as regards the vaginal cuff complications .
Detailed Description
All the women will subject to: Preoperative Assessment including: Detailed history taking including age ,parity, medical ,surgical history . Physical examination: General examination including the body mass index . Abdominal examination including presence of previous scars, uterine size , any tenderness and presence of palpable masses . Pelvic examination: including uterine size, any adnexal mass and tenderness . Preoperative investigation: A preoperative trans-vaginal ultra- sonography to assess the volume of the uterus, gross uterine pathology and any adnexal pathology. The preoperative laboratory investigation: hemoglobin percent and haematocrit value, blood grouping ,liver and kidney function tests. Availability of blood was ensured for each patient before surgery. Anaesthesia: Standardized general anaesthetic technique consisting of induction agent, muscle-relaxant and inhalational agents with basic minimum monitoring after a detailed pre-anaesthetic check-up and adequate premedication advice. Intraoperative : For vaginal cuff closure both in laparoscopic approach and vaginal route, the investigators will use the horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, and will continue toward the surgeon , using a continuous Vicryl suture . In the laparoscopic approach, needles will be introduced through one trocar and removed through the opposite trocars using a needle holders. Postoperative care: The patient will receive IV fluids in the first 24hours (3litres). Oral clear fluid intake will be started 8 hours after the operation. Another dose of antibiotics will be received 6hrs after the operation with the same regimen used in induction. Postoperative analgesia will be received in the form of parental NSAIDs every 8hrs for 24hrs then on demand. The urinary catheter and the vaginal pack will be removed 24hrs after the operation , no drains will be left intraoperative. CBC will be done 24hrs after the operation. Histopathological examination of the specimen will be done. Precocious resumption of coital activity ,( all patients will be recommended to avoid vaginal intercourse for at least 2 months ) . Follow Up: Transvaginal ultrasound will be done to all patients in the second day to Spot vaginal cuff hematoma if found . Women will be discharged on antibiotic ( third generation cephalosporins ) and analgesics ( NSAIDs ) and a follow-up visit will be scheduled after 7 days for a full examination to exclude vaginal cuff infection ( purulent drainage from the vaginal cuff on gross anatomic exam according to CDC ) or cuff hematoma (Any blood collection at the level of vaginal vault detected by transvaginal ultrasound). All women will be followed up after 3 months for the occurrence of vaginal cuff dehiscence (separation of a vaginal incision that was previously closed at time of initial hysterectomy) , at that time all women will undergo abdominal examination and bimanual pelvic examination for vaginal masses. All women will be asked for dyspareunia according to Marinoff scale: 0= no pain with intercourse . pain with intercourse that doesn't prevent the completion . pain with intercourse requiring interruption or discontinuance . pain with intercourse preventing any intercourse . Ethical Considerations: Patient information and informed consent: Before being admitted to the clinical study, the patient must consent to participate after the nature, scope and possible consequences of the clinical study have been explained in a form understandable to her. Protocol approval: Before the beginning of the study and in accordance with the local regulation followed, the protocol and all the corresponding documents will be declared for Ethical and Research approval by the council of the OB/GYN department, Ain Shams University. Assessment of the outcomes: Primary outcomes: 1. Vaginal cuff dehiscence: Any separation at the level of the vaginal vault. Secondary outcomes: Vaginal cuff hematoma: Any blood collection at the level of vaginal vault detected by transvaginal ultrasound. Post operative pelvic infections: Any postoperative infection with signs and symptoms of vaginal cuff involvement including granulation formation . Operative time: Time spent in suturing the vaginal cuff transvaginally versus laparoscopically . Incidence of dyspareunia : according to Marinoff scale .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Cuff Dehiscence, Vaginal Hematoma, Vaginal Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
neither the paticipant nor the investigator knew type of vaginal cuff closure
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopical l cuff closure
Arm Type
Active Comparator
Arm Description
needle holder laparoscopic vaginal cuff closure
Arm Title
transvaginal cuff closure
Arm Type
Active Comparator
Arm Description
transvaginal cuff closure
Intervention Type
Biological
Intervention Name(s)
laparoscopical l cuff closure
Other Intervention Name(s)
transvaginal cuff closure
Intervention Description
closure of vaginal cuff following hysterectomy
Primary Outcome Measure Information:
Title
1. number of cases ofVaginal cuff dehiscence
Description
Any separation at the level of the vaginal vault.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
number of cases with vaginal hematoma
Description
ultrasound finding
Time Frame
3 months
Title
number of cases with vaginal infection
Description
purulent vaginal discharge
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients candidate for total laparoscopic hysterectomy : Uterine size <12 weeks. Having no severe endometriosis. Having descent of no more than 1st degree of uterus. Non-malignant conditions. Completion of the entire procedure by laparoscopic approach up to colpotomy. Benign conditions as indications for hysterectomy. Exclusion Criteria: - 1) Obese patients i.e., BMI > 30 k.g\m2. 2) Suspected extensive pelvic adhesions . 3) Factors which may prolong wound healing as uncontrolled diabetes, ,prolonged corticosteroid therapy ,advanced liver diseases. 4) Inability to express adequate informed consent to participate in the study.
Facility Information:
Facility Name
Ain Shams university
City
Cairo
ZIP/Postal Code
11111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Laparoscopic Versus Transvaginal Cuff Closure

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