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REPLY TO: THE LETTER TO THE EDITOR BY ROBLEDO ET AL (Generalizability from well-designed RCT's underpin their scientific strength) [Letter]

Nezhat, Farr R; Ananth, Cande V; Vintzileos, Anthony M
PMID: 31472108
ISSN: 1097-6868
CID: 4054052

Two Achilles Heels of Surgical Randomized Controlled Trials: Differences in Surgical Skills and Reporting of Average Performance

Nezhat, Farr R; Ananth, Cande V; Vintzileos, Anthony M
Randomized controlled trials (RCT)s of surgery are fundamentally different from RCTs of medications because it is difficult to blind or mask a surgical procedure or perform "sham' operations. An additional challenge is the variation in skills and surgical proficiency of participating centers and surgeons. Addressing heterogeneity in surgical proficiency remains of paramount importance, especially when RCTs involve a new or complex procedure such as minimally invasive radical surgery. In the presence of such heterogeneity, it is very cumbersome to objectively evaluate and monitor surgical skills so that most trials simply report associations that are averaged across surgeons and hospitals/centers. Such reporting is non-transparent because the rates of complications and adverse outcomes are reported only as averages, and these averages may not apply to the individual participating surgeons or centers. These factors, coupled with the inherent non-generalizability of findings from such RCTs - due to the strict inclusion and exclusion criteria for enrollment - may lead to conclusions that no longer apply to real life for individual surgeons or centers. Case in point is a recently published non-inferiority RCT that reported that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival (86% versus 96.5% at 4.5 years) and overall survival (93.8% versus 99% at 3 years) than open abdominal radical hysterectomy in patients with cervical cancer. However, RCTs involving two competing complex or new procedures may be affected by tremendous confounding due to variations in surgical proficiency and also non-standardization for other confounding factors such as patient selection categories (i.e. stage of cancer) and adjuvant post-operative therapies that may affect long-term survival. The purpose of this Viewpoint is not to provide an exhaustive review of the trial but to use it as an illustration to focus on two challenging areas that most RCTs of a new complex surgical procedure suffer from: un-adjusting or not correcting for surgical skill variability and non-transparent reporting of averaged results. We provide suggestions to overcome these deficiencies through robust methodological and statistical approaches.
PMID: 31121141
ISSN: 1097-6868
CID: 3920902

51: Robot assisted repair of vesico-utero/cervico-vaginal fistula

Wells, M; Wang, P; Martinelli, V; Mesbah, M; Lazarou, G; Nezhat, F
CINAHL:135054879
ISSN: 0002-9378
CID: 3818912

Opportunistic salpingectomy: an appropriate procedure during all pelvic surgeries [Editorial]

Nezhat, Farr R; Martinelli, Vanessa T
PMID: 30591117
ISSN: 1097-6868
CID: 3563022

Vaginal Cuff Dehiscence and Evisceration: A Review

Nezhat, Camran; Kennedy Burns, Megan; Wood, Michelle; Nezhat, Ceana; Nezhat, Azadeh; Nezhat, Farr
Vaginal cuff dehiscence is an infrequent complication of hysterectomy, with the potential for evisceration and additional morbidity. This review aims to describe the incidence, risk factors, preventative measures, and management. Identification of specific risk factors is problematic because many studies either lack comparison groups or are underpowered as a result of the rarity of this complication. Good surgical technique to optimize vaginal cuff healing and minimize the risk of postoperative cuff infection are important as is avoidance of early intercourse, traumatic vaginal penetration, or excess strain on the vaginal cuff during the postoperative period. Judicious use of electrocautery or other thermal energy, use of delayed absorbable sutures, and adequate tissue bites can further decrease the risk of dehiscence. Prompt recognition and management are critical to achieve best outcomes.
PMID: 30204700
ISSN: 1873-233x
CID: 5020592

Bowel endometriosis: diagnosis and management

Nezhat, Camran; Li, Anjie; Falik, Rebecca; Copeland, Daniel; Razavi, Gity; Shakib, Alexandra; Mihailide, Catalina; Bamford, Holden; DiFrancesco, Lucia; Tazuke, Salli; Ghanouni, Pejman; Rivas, Homero; Nezhat, Azadeh; Nezhat, Ceana; Nezhat, Farr
The most common location of extragenital endometriosis is the bowel. Medical treatment may not provide long-term improvement in patients who are symptomatic, and consequently most of these patients may require surgical intervention. Over the past century, surgeons have continued to debate the optimal surgical approach to treating bowel endometriosis, weighing the risks against the benefits. In this expert review we will describe how the recommended surgical approach depends largely on the location of disease, in addition to size and depth of the lesion. For lesions approximately 5-8 cm from the anal verge, we encourage conservative surgical management over resection to decrease the risk of short- and long-term complications.
PMID: 29032051
ISSN: 1097-6868
CID: 5020562

Case of Psoas Abscess after Robotic-Assisted Laparoscopic Hysterectomy and Pelvic Lymphadenectomy [Case Report]

Rigaud, Vanessa; Wang, Pengfei; Bartalot, Ashley; Nezhat, Farr
Iliopsoas abscess (IPA) is a rare condition seen in a variety of specialties that presents with nonspecific complaints. Presented herein is the development of an IPA after robotic staging with sentinel lymphadenectomy for endometrial carcinoma. The patient was a 61-year-old woman with history of prolonged immunosuppressive therapy due to psoriasis. She presented with an IPA 8 weeks after a robotic-assisted laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and sentinel lymph node dissection. The patient was treated and cured with empiric antibiotics and drainage by interventional radiology. Although infrequent, one must keep IPA as a possible diagnosis in immunosuppressed patients who have undergone dissection of the retroperitoneal space during gynecologic surgery.
PMID: 29146389
ISSN: 1553-4669
CID: 5020572

Author's Reply [Letter]

Vahanian, Sevan A; Chavez, Martin R; Murphy, Jean; Vetere, Patrick; Nezhat, Farr; Vintzileos, Anthony M
PMID: 29763653
ISSN: 1553-4669
CID: 3442892

Ultrasound-Guided Laparoscopic-Assisted Abdominal Cerclage in Pregnancy

Vahanian, Sevan A; Chavez, Martin R; Murphy, Jean; Vetere, Patrick; Nezhat, Farr R; Vintzileos, Anthony M
PMID: 28602787
ISSN: 1553-4669
CID: 3442842

Exploring the umbilical and vaginal port during minimally invasive surgery

Tinelli, Andrea; Tsin, Daniel A; Forgione, Antonello; Zorron, Ricardo; Dapri, Giovanni; Malvasi, Antonio; Benhidjeb, Tahar; Sparic, Radmila; Nezhat, Farr
This article focuses on the anatomy, literature, and our own experiences in an effort to assist in the decision-making process of choosing between an umbilical or vaginal port. Umbilical access is more familiar to general surgeons; it is thicker than the transvaginal entry, and has more nerve endings and sensory innervations. This combination increases tissue damage and pain in the umbilical port site. The vaginal route requires prophylactic antibiotics, a Foley catheter, and a period of postoperative sexual abstinence. Removal of large specimens is a challenge in traditional laparoscopy. Recently, there has been increased interest in going beyond traditional laparoscopy by using the navel in single-incision and port-reduction techniques. The benefits for removal of surgical specimens by colpotomy are not new. There is increasing interest in techniques that use vaginotomy in multifunctional ways, as described under the names of culdolaparoscopy, minilaparoscopy-assisted natural orifice surgery, and natural orifice transluminal endoscopic surgery. Both the navel and the transvaginal accesses are safe and convenient to use in the hands of experienced laparoscopic surgeons. The umbilical site has been successfully used in laparoscopy as an entry and extraction port. Vaginal entry and extraction is associated with a lower risk of incisional hernias, less postoperative pain, and excellent cosmetic results.
PMCID:5590211
PMID: 28890429
ISSN: 1309-0399
CID: 5020552