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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy

NCT01064128

Uterine Myoma Uterine Adenomyosis

COMPLETED PHASE3

Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique

NCT01830738

Hysterectomy

TERMINATED NA

ESP vs TAP in Total Laparoscopic Hysterectomy

NCT04839445

Anesthesia Gynecologic Cancer

COMPLETED NA

Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease

NCT01679548

Benign or Preinvasive Uterine Disease

COMPLETED NA

Two-channel Intravenous Patient-controlled Analgesia (IV-PCA) After Total Laparoscopic Hysterectomy (TLH)

NCT04082039

Total Laparoscopic Hysterectomy Patient-controlled Analgesia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Disease Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single-port laparoscopic hysterectomy

total laparoscopic hysterectomy via transumbilical single port

Group Type EXPERIMENTAL

single-port laparoscopic hysterectomy(single port trochar)

Intervention Type DEVICE

perform laparoscopic hysterectomy via single-port access

multi-port laparoscopic hysterectomy

total laparoscopic hysterectomy via multi-port (3 port)

Group Type ACTIVE_COMPARATOR

multi-port laparoscopic hysterectomy(multi port trochar)

Intervention Type DEVICE

perform laparoscopic hysterectomy via multi-port access

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

single-port laparoscopic hysterectomy(single port trochar)

perform laparoscopic hysterectomy via single-port access

Intervention Type DEVICE

multi-port laparoscopic hysterectomy(multi port trochar)

perform laparoscopic hysterectomy via multi-port access

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

1. suspicion of malignancy
2. the need for simultaneous interventions such as prolapse repair
3. uterine size greater than 18 weeks of gestation
4. ongoing peritoneal dialysis
5. diseases associated with abdominal pain such as pancreatitis

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No