Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare postoperative pain between single-port access total laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients and postoperative pain and operative outcomes were examined.

Detailed Description
-----------------
The randomization code was inserted into numbered and sealed envelopes. A single envelope was opened when the patient was arrived in operating room. All patients gave their informed consent for the study and underwent hysterectomy for benign diseases. After surgery, in all patients, three sticking plasters were applied by the same manner with three port surgery group therefore not only patients but also anesthesiology staff who measure the pain score could not know the type of surgery until data collection was finished. Pain was assessed according to the visual analog scale (VAS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded at least at 30 minutes, 1, 12, 24 and 48 hours after surgery. Postoperative pain was measured by two independent anesthesiology staff members for cross-checking. In order to compare the intensity of postoperative pain accurately, all the participants had anesthesia in the same way and postoperative pain was managed by fentanyl-based intravenous patient-controlled analgesia pump (IV-PCA, Baxter healthcare Corporation, U.S.A: bolus dose 0.12mg/kg of fentanyl, lockout interval of 5 min, basal infusion 0.02ml/kg) with the same regimen on both groups. A patient was instructed to press the IV-PCA bolus button when the VAS was 3 or higher. A patient under IV-PCA whose VAS was over 5 received 50mg of Tridol injection intravenously. IV-PCA was removed 48 hours after surgery unless a patient specially asked it. Then, using log data downloaded by a program, we analyzed the number of IV-PCA bolus requests by time interval, total amount of fentanyl consumption, and the number of additional Tridol administration and injection time.

Official Title
-----------------
Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Transumbilical Single-port Access and Conventional Three-port Laparoscopic Surgery

Conditions
-----------------
Uterine Disease, Postoperative Pain

Intervention / Treatment
-----------------
* Device: single-port laparoscopic hysterectomy(single port trochar)
* Device: multi-port laparoscopic hysterectomy(multi port trochar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Incluson Criteria Subject has benign uterine disease Subject needs total hysterectomy. Subject has appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification system 1-3). Exclusion Criteria: suspicion of malignancy the need for simultaneous interventions such as prolapse repair uterine size greater than 18 weeks of gestation ongoing peritoneal dialysis diseases associated with abdominal pain such as pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-port laparoscopic hysterectomy<br>total laparoscopic hysterectomy via transumbilical single port | Device: single-port laparoscopic hysterectomy(single port trochar)<br>* perform laparoscopic hysterectomy via single-port access<br>|
| Active Comparator: multi-port laparoscopic hysterectomy<br>total laparoscopic hysterectomy via multi-port (3 port) | Device: multi-port laparoscopic hysterectomy(multi port trochar)<br>* perform laparoscopic hysterectomy via multi-port access<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain (Pain scores) intensity measure | self reported pain intensity measure for 2 days after surgery | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse events | perioperative adverse event including bowel, bladder injury and severe hemorrahge | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, hysterectomy, single-port access laparoscopy, multi-port access laparoscopy, TLH