NIHR Delivery Q2 Recruitment Recruitment Research Title REC Reference Target Date Project Status Target Met ARRIVE - Aspirin to Reduce Risk of Initial Vascular Events - A randomised, double-blind, placebo-controlled, multicenter, parallel group study to assess the efficacy (reduction of cardiovascular disease events) and safety of 100mg enteric-coated acetylsalALTITUDE
MAURICIO RUBINSTEIN, ANTONIO FINELLI, ALIREZA MOINZADEH, DINESH SINGH, OSAMU UKIMURA, MIHIR M. DESAI, JIHAD H. KAOUK, AND INDERBIR S. GILL ABSTRACT
Objectives. To assess the feasibility of ambulatory laparoscopic pyeloplasty. Laparoscopic pyeloplasty aims
to reproduce the excellent functional outcomes of open pyeloplasty while diminishing procedural morbidity.
Methods. Six patients fulfilled specific inclusion criteria for outpatient laparoscopic pyeloplasty: informed
consent, body mass index of 40 kg/m2 or less, primary ureteropelvic junction obstruction, uncomplicated
laparoscopic surgery completed by 12:00 PM, and postoperative pain control by oral analgesics. All patients
had a double-J ureteral stent placed cystoscopically before laparoscopic access. No drains were placed
Results. All 6 patients successfully underwent laparoscopic dismembered pyeloplasty (3 left, 3 right) using
the retroperitoneal (n ϭ 5) or transperitoneal (n ϭ 1) approach. The average patient age was 22 years. The
mean surgical time was 223 minutes (range 165 to 270), the mean blood loss was 82 mL (range 10 to 250),
and the mean postoperative hospital stay was 359 minutes (range 226 to 424). Postoperative analgesia
comprised a mean of 6 mg morphine sulfate and 32 mg of ketorolac. No complications or readmissions
occurred postoperatively. Intravenous urography and Lasix technetium-99m mercaptoacetyltriglycine renal
scans documented resolution of obstruction. With long-term follow-up (mean 38.4 months), no recurrences
Conclusions. We report our initial series of ambulatory laparoscopic pyeloplasty. In this well-selected
patient population, outpatient pyeloplasty was feasible and safe.
UROLOGY 66: 41–44, 2005. 2005
With increasing experience and technique re- ureteropelvic junction (UPJ) obstruction. Al-
finements, select laparoscopic procedures though antegrade or retrograde endopyelotomy is across various surgical disciplines have been per- a considerably less-invasive alternative, its success formed in an ambulatory setting. Laparoscopic gy- rates have only been 70% to 89% even in well- necologic procedures such as pelvic adhesiolysis (including endometriosis surgery) and general bines the excellent functional outcomes of open surgical procedures such as laparoscopic cholecys- surgery with a 1 to 2-day hospital stay and dimin- tectomy, inguinal herniorrhaphy, incidental ap- ished morbidity. We report our experience with pendectomy, and Nissen fundoplication have been outpatient laparoscopic pyeloplasty.
performed in an ambulatory setting with good re-In 2000, we reported our initial series of MATERIAL AND METHODS
Open pyeloplasty, with its success rates consis- Six select patients underwent outpatient laparoscopic py- tently greater than 90%, has until recently been eloplasty. The inclusion criteria fulfilled by each patient arelisted in Specifically, each patient expressed an under- considered the reference standard treatment for standing of, and willingness to undergo, the proposed proce-dure in an outpatient setting. Each laparoscopic pyeloplasty From the Section of Laparoscopic and Robotic Surgery, Glickman was the first case in the morning (first round start), the pro- Urological Institute, Cleveland Clinic Foundation, Cleveland, cedure was technically uncomplicated, and was completed by 12:00 PM. All patients were hemodynamically stable intraop- Reprint requests: Inderbir S. Gill, M.D., M.Ch., Section of eratively and postoperatively. At the conclusion of the proce- Laparoscopic and Robotic Surgery, Glickman Urological Insti- dure, the operating surgeon (I.S.G.) confirmed with the staff tute, A100, Cleveland Clinic Foundation, 9500 Euclid Avenue, anesthesiologist that the patient had no anesthesia-related Cleveland, OH 44195. E-mail: firstname.lastname@example.org contraindications to same-day discharge.
Submitted: October 26, 2004, accepted (with revisions): Feb- Between 2000 and 2004, we have performed 55 laparo- scopic pyeloplasties for UPJ obstruction, 35 primary (64%) Outpatient laparoscopic
pyeloplasty inclusion criteria
Six patients fulfilled the inclusion criteria for am- bulatory laparoscopic pyeloplasty. None of the 6 Patient and family agreeable to discharge plan patients experienced any complications or re- quired readmission. All 6 patients were males aged 12 to 48 years (mean 22). Three patients had a crossing vessel. The mean surgical time was 223 minutes (range 165 to 270), and all procedures The mean postoperative hospital stay (from ad- mission into the postanesthesia care unit to hospi- tal discharge) was 5.9 hours (range 3.7 to 7). The mean analgesia requirements comprised 6 mg mor- Ambulating without significant difficulty phine sulfate and 32 mg ketorolac. The 3 patients Abdomen soft, tolerating liquids orallyPain under control on oral analgesics from the Cleveland Clinic area were discharged tohome, and the 3 patients from outside Cleveland KEY: UPJ ϭ ureteropelvic junction. were discharged to an adjacent, geographicallyfree-standing guesthouse. At 6 weeks of follow-up,flank pain had improved in all patients. Pain had and 20 secondary (36%). Of these patients, 24 (53%) had their completely resolved in 3 patients and was rated as surgery performed as the first case of the day (first round 2 in 2 patients and 3 in 1 patient. Lasix technetium- start). Of the entire cohort, 13 patients had primary UPJ ob-struction and were first round starts. Six of the 13 patients 99m mercaptoacetyltriglycine radionuclide renal fulfilled all preoperative, intraoperative, and postoperative cri- scan at 2 months postoperatively confirmed reso- teria for outpatient laparoscopic pyeloplasty.
lution of obstruction in each patient. During a me- Laparoscopic pyeloplasty was performed using a retroperi- dian follow-up of 38.4 months, no patient reported toneal (n ϭ 5) or transperitoneal (n ϭ 1) approach. A three to four-port technique was used to perform a dismemberedAnderson-Hynes pyeloplasty (3 left, 3 right). All patients hada 4.7F, 26-cm double-J stent placed cystoscopically preoper-atively. No drains or nephrostomy tubes were placed in any patient. All patients received prophylactic intravenous antibi-otics and were discharged home with oral antibiotics and a Several minimally invasive alternatives for repair of UPJ obstruction have been developed to mini- The choice of the primary anesthetic agent, dependent on mize the usual postoperative morbidity associated the staff anesthesiologist, included propofol in 3 patients and with major open flank surgery. Open pyeloplasty isoflurane in 3. Preemptive analgesia was not given. Bupiva-caine (2%) was instilled subcutaneously around the port sites has been considered the reference standard for the before port placement and at the conclusion of the procedure.
correction of UPJ obstruction, with success rates Ketorolac 30 mg intravenously was administered in the oper- exceeding 90%. Although percutaneous antegrade ating room before completing the procedure. In the postanes- and ureteroscopic retrograde endopyelotomy are thesia care unit, standard monitoring, administration of par- associated with a shorter hospital stay and more enteral analgesics and antiemetics, and discharge to the step- rapid recovery, these endourologic techniques down observation unit were done at the discretion of the staffanesthesiologist. In the step-down observation unit, liquids have lower success rates (76% to 90%), even in were provided orally and patients ambulated. Analgesia in- cluded parenteral ketorolac supplemented with oral oxyc- Depending on the availability of expertise, lapa- odone as necessary. In each instance, the operating surgeon roscopic pyeloplasty is now a viable alternative evaluated the clinical status 3 to 4 hours postoperatively and for patients with UPJ obstruction. Jarrett et consulted with the patient and family before deciding on dis-charge from the hospital. In the study group, 3 patients were reported a 96% success rate with laparoscopic py- from the Cleveland area and 3 lived outside Cleveland. The eloplasty in 100 cases, with a mean clinical and patient was given a telephone and/or pager number to directly radiographic follow-up of 2.7 and 2.2 years, re- contact the operating surgeon in case of an emergency. The spectively. Similar to open surgery, laparoscopic operating surgeon spoke with each patient by telephone on pyeloplasty is capable of addressing various clini- the night of hospital discharge to ensure continued well-being.
Patients were required to contact the surgeon or a designated cal situations of UPJ obstruction, including severe clinical nurse on the first postoperative day to provide an hydronephrosis, redundant pelvis requiring reduc- update on their clinical status. The patient was instructed on tion, concomitant renal pelvic calculi, high ure- how to remove the Foley catheter on the second postoperative teral insertion, crossing renal vessels, secondary day. The double-J stent was removed 1 month postopera- UPJ after prior failed intervention, and UPJ ob- tively, and a Lasix technetium-99m mercaptoacetyltriglycinerenal scan was obtained 2 months postoperatively to docu- struction in anatomic variants such as horseshoe ment upper tract drainage. Patients were asked to rate their and pelvic kidneys. Notably, laparoscopic dismem- bered flap pyeloplasty has been performed success- UROLOGY 66 (1), 2005
fully even for a recalcitrant, scarred, obstructed Outpatient laparoscopic surgery may offer some advantages for a select group of patients. With fi- We first reported on ambulatory laparoscopic nancial costs assuming increasing importance, minimizing the hospital stay should lead directly lected patients with a mean age of 53 years and to decreased treatment costs. The cost of laparo- average adrenal tumor size of 2 cm. The mean sur- scopic herniorrhaphy was approximately $2000 gical time was 2.3 hours, and the mean blood loss less when performed at an ambulatory surgical was 53 mL. The average postoperative hospital stay center instead of a hospital Intuitively, was 416 minutes (range 300 to 570). The only earlier patient ambulation and discharge should complication was a local abscess requiring delayed decrease postoperative complications, such as atel- drainage at 2 weeks. Ambulatory adrenalectomy ectasis, nosocomial infection, thrombophlebitis, was feasible and safe, and resulted in high patient and deep vein thrombosis. However, a prospective randomized comparison of ambulatory versus In this study, we extended this concept to outpa- overnight laparoscopic pyeloplasty is necessary to tient laparoscopic pyeloplasty. Each patient was determine whether these potential benefits materi- required to fulfill all preoperative, intraoperative, alize and are statistically and clinically significant.
and postoperative inclusion criteria to qualify foroutpatient discharge The operating sur- CONCLUSIONS
geon counseled each patient preoperatively regard- With an experienced laparoscopic surgeon at a ing the laparoscopic pyeloplasty experience, with medical center accustomed to a high volume of emphasis on patient expectations of the outpatient laparoscopic procedures, outpatient laparoscopic discharge criteria. Of the 13 patients who fulfilled pyeloplasty is feasible and safe. Meticulous patient the preoperative inclusion criteria, 7 (54%) did not selection, careful evaluation before hospital dis- fulfill the intraoperative and/or postoperative cri- charge, and close follow-up are mandatory.
teria for the following reasons: pain control issuesin 4, nausea in 2, and intraoperative drain place- ment in 1. These 7 patients were discharged home 1. Fiorillo MA, Davidson PG, Fiorillo M, et al: 149 ambu- after a mean hospital stay of 30 hours.
latory laparoscopic cholecystectomies. Surg Endosc 10: 52–
Ambulatory laparoscopic surgery expresses a natural evolution of minimally invasive surgery.
2. Evans DS, Ghanesh P, and Khan IM: Day-case laparo- However, some important points must be kept in scopic hernia repair. Br J Surg 83: 1361–1363, 1996.
mind. Patient safety should be the paramount con- 3. Jain A, Mercado PD, Grafton KP, et al: Outpatient lapa- roscopic appendectomy. Surg Endosc 9: 424 – 425, 1995.
sideration at all times. Patient selection must be 4. Gill IS, Hobart MG, Schweizer D, et al: Outpatient ad- judicious, and strict inclusion criteria should be renalectomy. J Urol 163: 717–720, 2000.
developed. Older or higher risk surgical patients 5. Van Cangh PJ, Wilmart JF, Opsomer RJ, et al: Long- requiring a prolonged operative time should be ex- term results and late recurrence after endoureteropyelotomy: cluded. Laparoscopic cholecystectomy in high-risk a critical analysis of prognostic factors. J Urol 151: 934 –937,
patients (American Society of Anesthesiologists 6. Motola JA, Badlani GH, and Smith AD: Results of 212 class greater than 3) resulted in a greater hospital consecutive endopyelotomies: an 8-year followup. J Urol 149:
admission rate than in those at lower risk (28% versus Similarly, laparoscopic cholecystec- 7. Jarrett TW, Chan DY, Charambura TC, et al: Laparo- tomy in patients older than 70 years resulted in a scopic pyeloplasty: the first 100 cases. J Urol 167: 1253–1256,
70% hospital admission The same study re- 8. Kaouk JH, Kuang W, and Gill IS: Laparoscopic dis- ported that the hospital admission rate after lapa- membered tubularized flap pyeloplasty: a novel technique.
roscopic procedures lasting longer than 1 hour was J Urol 167: 229 –231, 2002.
four times greater than after those lasting less than 9. Votik AJ: Is outpatient cholecystectomy safe for the 1 hour. Thus, standard and objective intraopera- higher-risk elective patient? Surg Endosc 11: 1147–1149,
tive and discharge criteria for outpatient surgery 10. Cuschieri A: Day-case (ambulatory) laparoscopic sur- should be developed and implemented. These cri- gery. Let us sing from the same hymn sheet. Surg Endosc 11:
teria should also consider subjective issues, such as individual motivation and preference and the geo- 11. Skattum J, Edwin B, Trondsen E, et al: Outpatient lapa- graphic distance of the patient’s place of residence roscopic surgery: feasibility and consequences for education
and health care costs. Surg Endosc 18: 796 – 801, 2004.
from the hospital. Immediate access to the operat-ing surgeon and meticulous follow-up with a des- ignated study nurse and/or the referring physician The authors should be congratulated on a well-executed are imperative to diminish the risk of delayed di- pilot study demonstrating the feasibility of performing laparo- agnosis and management of postoperative compli- scopic pyeloplasty as an outpatient procedure. The issue of outpatient laparoscopic pyeloplasty is salient as, at centers UROLOGY 66 (1), 2005
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