Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

Study Overview
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Brief Summary
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In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups: transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and costs.

Detailed Description
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Women assigned to laparoscopic surgery for removal of a benign adnexal mass were randomly divided into two groups as regards surgery: a transumbilical (TU) group (n=21) and a transabdominal (TA) group (n=21). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours. Investigators also investigated the expenses related to endobags and trocars. Further, peri- and postoperative complications were recorded. Investigators inquired about patient satisfaction as well as the surgeons' opinions of the alternative methods available.

Official Title
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Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy, a Randomized Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Transumbilical removal of specimen via laparoscopy
* Procedure: Lateral transabdominal removal of specimen via laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The criteria for inclusion were scheduled laparoscopy for oophorectomy, salpingo-oophorectomy or cyst enucleation. Exclusion Criteria: The exclusion criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol), language difficulties (inability to understand and speak Finnish or Swedish) and suspicion of malignancy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transumbilical route<br>Transumbilical removal of benign adnexal masses via laparoscopy. | Procedure: Transumbilical removal of specimen via laparoscopy<br>* Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy<br>* Other names: Transumbilical;|
| Active Comparator: Lateral abdominal route<br>Lateral transabdominal removal of benign adnexal masses via laparoscopy. | Procedure: Lateral transabdominal removal of specimen via laparoscopy<br>* Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy<br>* Other names: Lateral transabdominal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use of analgesics for postoperative pain | The total amount of analgesics used measured by use of Oxycodone (mg) | Change in 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Frequency of complications. Values are given as n (%) and eventual complications are specified | The first six months after the surgical intervention | 
| Nausea | Nausea after the procedure: Visual Analog Score (VAS) for nausea, to measure quality of nausea. 10-point VAS score for nausea [(0-10), 0 indicating no nausea and 10 indicating unbearable nausea. at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10) | Change in 24 hours after surgery | 
| Vomiting | Vomiting after the procedure: Visual Analog Score (VAS) for vomiting to measure quality of vomiting. 10-point VAS score for vomiting [(0-10), 0 indicating no vomiting and 10 indicating unbearable vomiting] at 1, 3, 6, 12 and 24 h (hour) after surgery. (Units on a Scale; 0-10) | Change in 24 hours after surgery | 
| Length of hospital stay in hours | Length of hospital stay measured from the end of the operation until discharge (hours) | Up to one week | 
| Quality of life | A questionnaire six months after operation concerning wellbeing outcome after six months (% of respondents in the group) | At baseline and 6 months after the surgery | 
| Cosmetic outcome | A questionnaire six months after operation concerning cosmetic outcome after six months (% of respondents in the group) | At baseline and 6 months after the surgery | 
| Costs | Calculating the comparative direct costs of both techniques. The cost of equipment used in the surgical intervention. (euros) | During the surgery | 
| Surgeon perception of both techniques | A questionnaire one month after operation of opinion of surgeons on preferred route of specimen removal (% of respondents in the group) | After one month after the operation | 
| Length of need of postoperative pain medication | A questionnaire of pain medication needed postoperatively. (Days) | Change in one month after surgery | 
| Postoperative pain scores | Visual Analog Score (VAS) for pain to measure quality of pain. 10-point VAS score for pain [(0-10), 0 indicating no pain and 10 indicating unbearable pain] at 1, 3, 6, 12 and 24 h (hour) after surgery (Units on a Scale; 0-10) | Change in 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adnexal mass, laparoscopy, removal route, postoperative pain