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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transumbilical route | Experimental | Transumbilical removal of benign adnexal masses via laparoscopy. |
|
| Lateral abdominal route | Active Comparator | Lateral transabdominal removal of benign adnexal masses via laparoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transumbilical removal of specimen via laparoscopy | Procedure | Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy |
|
| 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 |
| 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)](streamdown:incomplete-link) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Päivi I Pakarinen, MD PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kätilöopisto Maternity Hospital, Helsinki University hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17507163 | Background | Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15. | |
| 22224504 | Background | Nilsson L, Wodlin NB, Kjolhede P. Risk factors for postoperative complications after fast-track abdominal hysterectomy. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):113-20. doi: 10.1111/j.1479-828X.2011.01395.x. Epub 2012 Jan 8. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Lateral transabdominal removal of specimen via laparoscopy | Procedure | Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy |
|
|
| 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 |
| 18448418 | Background | Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. Premedication with pregabalin 75 or 150 mg with ibuprofen to control pain after day-case gynaecological laparoscopic surgery. Br J Anaesth. 2008 Jun;100(6):834-40. doi: 10.1093/bja/aen098. Epub 2008 Apr 29. |
| 22880948 | Background | Wodlin NB, Nilsson L. The development of fast-track principles in gynecological surgery. Acta Obstet Gynecol Scand. 2013 Jan;92(1):17-27. doi: 10.1111/j.1600-0412.2012.01525.x. Epub 2012 Nov 1. |
| 21306322 | Background | Wodlin NB, Nilsson L, Kjolhede P. Health-related quality of life and postoperative recovery in fast-track hysterectomy. Acta Obstet Gynecol Scand. 2011 Apr;90(4):362-8. doi: 10.1111/j.1600-0412.2010.01058.x. Epub 2011 Feb 18. |
| 16817084 | Background | Alessandri F, Lijoi D, Mistrangelo E, Nicoletti A, Ragni N. Effect of presurgical local infiltration of levobupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(7):844-9. doi: 10.1080/00016340500494846. |
| 20705381 | Background | Chou LY, Sheu BC, Chang DY, Huang SC, Chen SY, Hsu WC, Chang WC. Comparison between transumbilical and transabdominal ports for the laparoscopic retrieval of benign adnexal masses: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):198-202. doi: 10.1016/j.ejogrb.2010.07.029. Epub 2010 Aug 11. |
| 18715419 | Background | Ghezzi F, Cromi A, Uccella S, Siesto G, Bergamini V, Bolis P. Transumbilical surgical specimen retrieval: a viable refinement of laparoscopic surgery for pelvic masses. BJOG. 2008 Sep;115(10):1316-20. doi: 10.1111/j.1471-0528.2008.01802.x. |
| 22704765 | Background | Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23. |
| 24381621 | Background | Akdemir A, Ergenoglu AM, Akman L, Yeniel AO, Sendag F, Oztekin MK. A novel technique for laparoscopic removal of the fallopian tube after ectopic pregnancy via transabdominal or transumbilical port using homemade bag: A randomized trial. J Res Med Sci. 2013 Sep;18(9):777-81. |
| 8498433 | Background | Kadar N, Reich H, Liu CY, Manko GF, Gimpelson R. Incisional hernias after major laparoscopic gynecologic procedures. Am J Obstet Gynecol. 1993 May;168(5):1493-5. doi: 10.1016/s0002-9378(11)90787-x. |
| 23741110 | Background | Karthik S, Augustine AJ, Shibumon MM, Pai MV. Analysis of laparoscopic port site complications: A descriptive study. J Minim Access Surg. 2013 Apr;9(2):59-64. doi: 10.4103/0972-9941.110964. |
| 9166204 | Background | Jansen FW, Kapiteyn K, Trimbos-Kemper T, Hermans J, Trimbos JB. Complications of laparoscopy: a prospective multicentre observational study. Br J Obstet Gynaecol. 1997 May;104(5):595-600. doi: 10.1111/j.1471-0528.1997.tb11539.x. |
| 22763313 | Background | Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3. |
| 21902958 | Background | Yamamoto M, Minikel L, Zaritsky E. Laparoscopic 5-mm trocar site herniation and literature review. JSLS. 2011 Jan-Mar;15(1):122-6. doi: 10.4293/108680811X13022985131697. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |